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Effect of Luseogliflozin on myocardial flow reserve in patients with type 2 diabetes (Lucent-J Study)

Lucent-J Study (Lucent-J Study)

40

The PPS for this study was 33 cases.(17 in the luseogliflozin group and 16 in the control group). The sex ratio (male/female) for each allocation group was 9/8 in the luseogliflozin group and 9/7 in the control group; age was 72.7 +/- 9.5 years in the luseogliflozin group and 72.8 +/- 9.8 years in the control group. Duration of diabetes was 190.1 +/- 99.7 months in the luseogliflozin group and 211.3 +/- 139.7 months in the control group. There were no differences in patient background between the two groups.

Consent was obtained and cases were enrolled between August 2022 and June 2023, and the observation period ended on 6 March 2024. Of the 40 patients enrolled, out due to smoking before the start of the study treatment and one dropped out due to a diagnosis of malignancy, also before the start of the study treatment.Four cases that did not meet the inclusion criteria were excluded from the analysis. After the start of the study treatment, one case in the luseogliflozin group was lost to follow-up due to adverse events, resulting in 17 cases in the luseogliflozin group and 16 cases in the control group that completed the study, with a total of 33 cases included in the PPS analysis. One patient was unable to perform the assessment item, the urine ACR test, and was analysed as a missing value.

No cases of illness or other conditions were observed. There were 11 adverse events in 8 patients in the ruseogliflozin group and 5 in 3 patients in the control group. There were no differences in the incidence of adverse events between the two groups. Of the adverse events that occurred, one urinary tract infection reported with ruseogliflozin was potentially related to the study. The case was mild and resolved with oral antibiotic treatment.

Primary endpoint. The change in myocardial blood flow reserve (MFR) from baseline to 24 weeks was 0.087 +/-0.108 in the luseogliflozin group and 0.026 +/- 0.111 in the control group, with no difference between groups (p=0.699) . Secondary endpoints. The following differences between groups were observed from baseline to 24 weeks. For body weight, the difference between groups was -1.8 5+/- 2.24 in the luseogliflozin group and -0.01 +/- 1.46 in the control group (p = 0.009). In BMI, the luseogliflozin group was -0.75 +/- 0.89 and the control group -0.03 +/- 0.57, showing a difference between the groups (p=0.009). Haemoglobin was 0.53 +/- 0.71 in the luseogliflozin group and -0.15 +/- 0.83 in the control group, showing a difference between groups (p=0.017). The difference in haematocrit was 1.35 +/- 1.72 in the luseogliflozin group and -0.56 +/- 1.56 in the control group (p=0.007). HDL-C was 2 (-1, 4) in the luseogliflozin group and -5.0 (-7.5, 1.3) in the control group, showing a difference between groups (p=0.038). For uric acid, the difference between groups was -0.59 +/- 0.59 in the luseogliflozin group and 0.14 +/- 0.67 in the control group (p<0.001). LVEF was 2 (0, 4) in the luseogliflozin group and 0 (-3, 1) in the control group, showing a difference between groups (p=0.041). Within both groups, changes were observed in the following. Luseogliflozin group: body weight, BMI, haemoglobin, haematocrit, total bilirubin, gamma-GTP, LDH, Na, Cl, LDL-C, uric acid, HbA1c, acetoacetic acid, beta hydroxybutyrate, urine albumin/creatinine ratio. Control group: FBS, IRI, BNP. No significant differences were found between the two groups in the change in MFR when divided into high and low MFR groups by median MFR data at baseline.

The PPS for this study was 33 cases. (16 in the control group and 17 in the luseogliflozin group). There was no difference in the change in myocardial flow reserve (MFR) from baseline to 24 weeks, the primary endpoint, between groups (p=0.699). In the secondary endpoints, a significant difference in LVEF was observed between the groups (p=0.041). Additionally, effects previously reported with SGLT2 inhibitors, such as weight loss were confirmed.

Aug. 31, 2025

No

N/A

https://jrct.mhlw.go.jp/latest-detail/jRCTs051220016

Tamanaha Tamiko

National Cerebral and Cardiovascular Center

6-1,Kishibe-shinmachi,Suita,Osaka

tamanaha.tamiko@ncvc.go.jp

Tamanaha Tamiko

National Cerebral and Cardiovascular Center

6-1,Kishibe-shinmachi,Suita,Osaka

+81-661701070

tamanaha.tamiko@ncvc.go.jp

Complete

April. 28, 2022

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1)Type 2 diabetic patients age 50 and over
2)Patients with HbA1c 8.5% or less (Most recent HbA1c within 13 weeks prior to consent)
3)Patients who received an ammonia PET examination before the date of consent acquisition, and MFR of 3.0 or less (Most recent MFR within 13 weeks prior to consent)
4)Patients with written consen

1) Patients with heart disease (myocardial infarction, cardiomyopathy, atrial fibrillation, severe valvular disease)
2) Patients who underwent cardiac bypass surgery or catheter treatment for ischemic heart disease within 13 weeks prior to consent
3) Patients with coronary artery disease who are indicated for coronary revascularization, or patients with suspected coronary artery disease who are indicated for coronary angiography
4) Persons with severe renal dysfunction
5) Patients with severe hepatic dysfunction (ALT or AST is 5 times or more of the standard value)
6) Patients with a malignant tumor currently being treated or during palliative care
7) Patients participating in or planning to participate in intervention studies using other medicines or medical devices
8) Smokers
9) Pregnant or lactating women
10) Patients with contraindications to luseogliflozin (hypersensitivity, severe ketosis, diabetic coma, severe infections, before or after surgery, serious trauma)
11) In the young old (65=<age<75) and latter-stage elderly (75=<age), it is a patient of the geriatric syndrome or BMI=<18
12) Patients who received SGLT2 inhibitors from 13 weeks before the ammonia PET examination to the date of consent acquisition
13) Patients who have newly started or changed or discontinued diabetes treatment drugs, nitroglycer in preparations, vasodilators, and antihypertensive drugs within 13 weeks before obtaining consent. However, temporary drug changes are allowed due to suspected ischemia on ammonia PET scans.
14) Patients whose participation in this study is deemed inappropriate by the investigator or co-investigator

Both

Type 2 diabetes mellitus

Luseogliflozin group: Luseogliflozin will be orally administered at 2.5 mg once daily. If the effect is insufficient, the dose can be increased up to 5 mg.
Control group: Continue treatment with treatments other than SGLT2 inhibitors.

Type 2 diabetes mellitus

D003924

Differences between the groups in the amount of change in myocardial microcirculatory reserve (MFR) 24 weeks after the start of administration

1)The amount of change in the following items within each group and the difference between the groups at the point in time of each measurement (4,12 and 24 weeks) from the start of administration:Weight; BMI; systolic blood pressure; diastolic blood pressure; hemoglobin; hematocrit; total protein; albumin; total bilirubin;AST; ALT; GTP; creatinine; eGFR; LDH; Ca; Na; K; Cl; LDL-C; HDL-C; TG; uric acid; CRP; FBS; IRI; HbA1c; acetacetic acid; B-hydroxybutyric acid; BNP;adrenomedulin; urinary albumin creatinine ratio and LVEF.
(2) Difference in the amount of change in MFR between the high MFR value group and the low MFR value group before administration.

+81-744298835

April. 07, 2022

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